A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects

This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin

开始日期2023-07-14

申办/合作机构

杭州先为达生物科技股份有限公司

100 项与伊诺格鲁肽相关的临床结果

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100 项与伊诺格鲁肽相关的转化医学

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100 项与伊诺格鲁肽相关的专利（医药）

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项与伊诺格鲁肽相关的文献（医药）

2025-06-01·Lancet Diabetes & Endocrinology

Efficacy and safety of a biased GLP-1 receptor agonist ecnoglutide in adults with overweight or obesity: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Article

作者: Guo, Tonglan ; Wen, Binhong ; Guo, Mengying ; Fu, Wenyan ; Tian, Junhang ; Zheng, Qing ; Yang, Ming ; Pan, Hai ; Lian, Qiufang ; Gao, Leili ; Gao, Ge ; Zhang, Yawei ; Ning, Jing ; Wang, Haifang ; Shi, Bimin ; Hu, Wen ; Shi, Xiaoguang ; Wang, Kun ; Ji, Linong ; Xing, Ying ; Lu, Yibing ; Li, Ya ; Li, Yao ; Huang, Chongbing ; Han, Jie ; Li, Qingju ; Jiang, Hongwei ; Yuan, Mingxia ; Xue, Haibo

BACKGROUND:

Ecnoglutide is a novel cyclic adenosine monophosphate (cAMP)-biased GLP-1 receptor agonist currently in development for weight management. We aimed to assess the efficacy and safety of once weekly ecnoglutide versus placebo for the treatment of overweight or obesity in Chinese adults.

METHODS:

This randomised, double-blind, placebo-controlled, phase 3 trial was done at 36 medical centres across China. Eligible adults were aged 18-75 years with overweight or obesity (defined as BMI ≥28 kg/m² or ≥24 kg/m² with at least one weight-related comorbidity [prediabetes, hypertension, hyperlipidaemia, metabolic dysfunction-associated steatotic liver disease, obstructive sleep apnoea syndrome, or weight-bearing joint pain]), without diabetes (type 1 or 2). Participants were randomly assigned (3:3:3:1:1:1) via computer-generated random sequencing to receive subcutaneous ecnoglutide (1·2, 1·8, or 2·4 mg) or volume-matched placebo (1·2, 1·8, or 2·4 mg), once weekly, stratified by BMI at screening (≥28 kg/m² and <28 kg/m²). The coprimary endpoints were percentage change in bodyweight and proportion of participants with a reduction in bodyweight of 5% or more at week 40 (using the treatment policy estimand in the full analysis set). The full analysis set included all randomly assigned participants who were exposed to at least one dose of study drug or placebo according to their assigned treatment group. Safety was assessed in all participants who received at least one dose and had a safety assessment after medication. This study was registered with ClinicalTrials.gov, NCT05813795, and is complete.

FINDINGS:

Between April 5, 2023, and June 20, 2024, 882 participants were screened and 664 were randomly assigned to receive ecnoglutide 1·2 mg (n=166), ecnoglutide 1·8 mg (n=166), ecnoglutide 2·4 mg (n=167), or placebo (n=165). At week 40, the least-squares mean percentage change in bodyweight was -9·1% (SE 0·8) in the ecnoglutide 1·2 mg group, -10·9% (0·9) in the ecnoglutide 1·8 mg group, and -13·2% (0·8) in the ecnoglutide 2·4 mg group versus 0·1% (0·8) in the placebo group, and the respective estimated treatment differences compared with placebo were -9·2% (97% CI -11·0 to -7·5), -11·1% (-13·1 to -9·1), and -13·3% (-15·3 to -11·3), respectively (all p<0·0001). The proportion of participants who achieved at least a 5% reduction in bodyweight at week 40 was 77% in the ecnoglutide 1·2 mg group, 84% in the ecnoglutide 1·8 mg group, and 87% in the ecnoglutide 2·4 mg group versus 16% of participants in the placebo group, and the respective estimated treatment differences versus placebo were 60% (98% CI 50 to 71), 68% (58 to 78), and 70% (61 to 80; all p<0·0001). Treatment-emergent adverse events were observed in 155 (93%) of 166 participants in the ecnoglutide 1·2 mg group, 154 (93%) of 166 participants in the ecnoglutide 1·8 mg group, 156 (93%) of 167 participants in the ecnoglutide 2·4 mg group, and 139 (84%) of 165 participants in the placebo group. The most common adverse events were mild-to-moderate gastrointestinal related events. Ten participants treated with ecnoglutide discontinued treatment due to adverse events.

INTERPRETATION:

In adults with obesity or overweight without diabetes (type 1 or 2), individuals administered ecnoglutide had superior and sustained reduction in bodyweight versus placebo with a favourable safety profile, supporting its potential use for weight management.

FUNDING:

Hangzhou Sciwind Biosciences.

2025-01-01·PHARMACOLOGICAL REVIEWS

Emerging pharmacotherapies for obesity: A systematic review

Review

作者: Al Rifai, Jana ; Valenzuela-Vallejo, Laura ; Rhayem, Caline ; Kokkorakis, Michail ; Mantzoros, Christos S ; Mantzoros, Christos S. ; Chakhtoura, Marlene ; Ghezzawi, Malak

The history of antiobesity pharmacotherapies is marked by disappointments, often entangled with societal pressure promoting weight loss and the prevailing conviction that excess body weight signifies a lack of willpower. However, categories of emerging pharmacotherapies generate hope to reduce obesity rates. This systematic review of phase 2 and phase 3 trials in adults with overweight/obesity investigates the effect of novel weight loss pharmacotherapies, compared to placebo/control or US Food and Drug Administration-approved weight loss medication, through searching Medline, Embase, and ClinicalTrials.gov (2012-2024). We identified 53 phase 3 and phase 2 trials, with 36 emerging antiobesity drugs or combinations thereof and 4 withdrawn or terminated trials. Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate. Completed phase 2 trials on incretin-based therapies showed a mean percent weight loss of 7.4% to 24.2%. Almost half of the drugs undergoing phase 2 trials are incretin analogs. The obesity drug pipeline is expanding rapidly, with the most promising results reported with incretin analogs. Data on mortality and obesity-related complications, such as cardio-renal-metabolic events, are needed. Moreover, long-term follow-up data on the safety and efficacy of weight maintenance with novel obesity pharmacotherapies, along with studies focused on underrepresented populations, cost-effectiveness assessments, and drug availability, are needed to bridge the care gap for patients with obesity. SIGNIFICANCE STATEMENT: Obesity is the epidemic of the 21st century. Except for the newer injectable medications, drugs with suboptimal efficacy have been available in the clinician's armamentarium for weight management. However, emerging alternatives of novel agents and combinations populate the current obesity therapeutic pipeline. This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives.

2024-06-02·Expert Review of Cardiovascular Therapy

Targeting obesity for therapeutic intervention in heart failure patients

Review

作者: Sato, Ryosuke ; von Haehling, Stephan

INTRODUCTION:

Heart failure with preserved ejection fraction (HFpEF) is a highly heterogeneous syndrome, making it challenging to improve prognosis with pharmacotherapy. Obesity is one of the leading phenotypes of HFpEF, and its prevalence continues to grow worldwide. Consequently, obesity-targeted interventions have attracted attention as a novel treatment strategy for HFpEF.

AREAS COVERED:

The authors review the association between the pathogenesis of obesity and HFpEF and the potential for obesity-targeted pharmacotherapeutic strategies in HFpEF, together with the latest evidence. The literature search was conducted in PubMed up to April 2024.

EXPERT OPINION:

The STEP HFpEF (Semaglutide Treatment Effect in People with obesity and HFpEF) and SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trials recently demonstrated that the glucagon-like peptide 1 analogue, semaglutide, improves various aspects of clinical outcomes in obese HFpEF patients and significantly reduces cardiovascular and heart failure events in non-diabetic obese patients, along with a substantial weight loss. Future clinical trials with other incretin mimetics with more potent weight loss and sub-analyses of the SELECT trial may further emphasize the importance of the obesity phenotype-based approach in the treatment of HFpEF.

146

项与伊诺格鲁肽相关的新闻（医药）

2025-06-30

·药闻康策

药闻康策一周药闻（6月23日-29日）

☝ 点击上方一键预约 ☝ 最新最热的医药健康新闻政策本周，2025年医保国谈又有新进展。6月26日，《2025年基本医保目录及商保创新药目录调整申报操作指南》在业界广为流传。传言称自2025年开始，谈判材料拟于线上申报。为了配合创新药的临床使用，国家卫健委本周公布《2025年三级医院绩效监测手册》明确，剔除纳入创新药应用指导目录中药品收入的考核。在药品集采方面，国家药监局召开集采中选药品风险沟通会，明确企业要切实承担主体责任，确保药品质量安全。医疗保障法（草案）全文本周正式公布，并向社会公开征求意见。医药反腐风暴一直没有停歇。本周全国政协经济委员会副主任、国家药监局原局长毕井泉被免职。贵州省人民医院原党委书记刘健因严重违纪违法被立案调查。而在公司层面，本周阿斯利康框架大调整、复星医药管理层“大换血”、ST葫芦娃及相关责任人被通报批评…………健识局整理更多热点如下：重磅政策一览1.国谈新进展6月26日，业内流传《2025年基本医保目录及商保创新药目录调整申报操作指南》，首次将商业健康保险创新药目录纳入调整方案。自2025年开始，谈判材料拟于线上填报，申报材料与谈判材料报送需使用同一账号，计划参与申报的药品，需充分准备基本信息、药品有效性、安全性、创新性、公平性等资料。2.创新药收入不再纳入医院考核6月27日，国家卫健委公布了《国家三级公立医院绩效监测操作手册（2025 版）》明确，剔除了创新药应用指导目录中药品收入相关的考核指标。此外，散装中药饮片、小包装中药饮片、中药配方颗粒剂、医疗机构中药制剂、罕见病用药收入同样不纳入考核之列。3.医疗保障法草案首次亮相据央视消息，《中华人民共和国医疗保障法（草案）》6月24日提请十四届全国人大常委会第十六次会议首次审议。本草案共7章50条，系统规定医疗保障体系框架、加强医疗保障基金运行管理、优化医疗保障服务、强化监督管理。6月27日，中国人大网公布医疗保障法（草案）全文，并向社会公开征求意见。4.毕井泉被免职据新华社消息，政协第十四届全国委员会常务委员会第十二次会议通过关于免去毕井泉第十四届全国政协常委、经济委员会副主任职务，撤销其委员资格的决定。毕井泉历任国家发展和改革委员会副主任，国务院副秘书长等职务，2015年任国家食品药品监督管理总局局长、党组书记，2018年任国家市场监督管理总局党组书记、副局长，同年因吉林长春长生公司问题疫苗案件引咎辞职。2020年，他任全国政协经济委员会副主任。今年5月29日晚消息，毕井泉涉嫌严重违纪违法被查。5.国家药监局召开集采中选药品风险沟通会6月26日，国家药监局召开集采中选药品风险沟通会。会议通报工作进展，研判安全风险，交流工作经验，部署下一阶段工作。会议要求，集采中选企业要切实承担主体责任，不断完善质量保证体系，确保药品质量安全；省级药监部门要落实属地监管责任，继续坚持并严格执行两个“全覆盖”，加强跨省和部门间协同治理。　医药卫生事件1.多名院长落马6月26日，贵州省纪委监委对贵州省人民医院原党委书记刘健严重违纪违法问题进行了立案审查调查。经查，刘健利用职务便利为他人在药品采购供应、医疗项目承接等方面谋取利益，并非法收受巨额财物。6月24日，西安市纪委监委网站发布消息，西安市精神卫生中心原党委副书记、院长吴强驹涉嫌严重违纪违法，主动投案，目前正接受西安市纪委监委纪律审查和监察调查。2.荣昌生物实现BD授权6月26日，荣昌生物发布公告称，将核心产品泰它西普在大中华区以外的权益授予美国生物技术公司Vor Bio。这笔交易涉及的总金额最高可达41.05亿美元，其中包括4500万美元首付款以及8000万美元的认股权证，后续还包含多项里程碑付款与产品销售分成。但消息公布后市场反应并不积极，受首付款规模低于预期、合作方“咖位”较小等因素影响，荣昌生物A股盘中一度跌停。公面回应财联社记者称“无法判断市场走势”，并否认此前外界关于200亿美元授权预期的传言。3.阿斯利康框架大调整6月25日，阿斯利康中国宣布，启动新一轮组织架构优化，新设立消化道肿瘤事业部、早期业务管线业务部两大全新业务板块。同时，阿斯利康中国宣布，任命王君为阿斯利康中国助理副总裁、肿瘤业务消化道肿瘤事业部负责人，现任消化道肿瘤市场部执行总监王海军与全国销售总监王慧丽将向其汇报。而早期业务管线业务部目前空缺，已面向内外部启动招聘。4.复星医药管理层“大换血”6月25日，复星医药发布公告称：选举陈玉卿为董事长、关晓晖为联席董事长、文德镛为副董事长。而刘毅出任首席执行官兼总裁，董晓娴为公司董事会秘书。李静、王兴利、张文杰则担任公司联席总裁。今年4月，复星医药原副总裁到包勤贵、李东久离职。随后因工作安排调整，吴以芳、王可心分别辞去公司董事长、联席董事长的职务。5.葫芦娃及相关责任人被通报批评6月24日，上交所对ST葫芦娃及时任董事长兼总经理刘景萍、财务总监于汇、董事会秘书王清涛予以通报批评，并将相关处分记入证券期货市场诚信档案。《公告》指出，公司未能在2024年会计年度结束后1个月内披露业绩预亏公告，迟至2025年4月23日才发布亏损预警，预计2024年度亏损2.5亿元至2.8亿元，较规定时限延误近四个月。一周药械盘点1.阿斯利康减重新药联合疗法在中国获批临床6月2日，中国国家药监局药品审评中心官网最新公示，阿斯利康申报的两款1类新药AZD6234注射液以及AZD9550注射液获得临床试验默示许可，拟定适应症为：肥胖成年人中的长期体重管理。公开资料显示，AZD6234是一款多肽类药物，为每周一次皮下注射的长效胰淀素受体激动剂，此前已经在中国获批临床，拟用于超重或者肥胖成年人中长期体重管理；AZD9550为每周一次的合成GLP-1/胰高血糖素（GCG）双受体激动剂，本次为该产品首次在中国获批临床。2.全球首个偏向型 GLP-1中国Ⅲ期临床数据公布本周，杭州先为达自主研发的减重药物埃诺格鲁肽注射液的Ⅲ期临床试验研究成果公布。结果表明：相比于安慰剂，埃诺格鲁肽治疗疗效显著且安全优势明显，减重幅度高达15.1%，创下目前中国人群Ⅲ期研究48周最高记录。该研究成果以口头报告形式公布于第85届美国糖尿病协会（ADA）学术会议公布，并全文同步在线发表于在国际顶级医学期刊《柳叶刀・糖尿病与内分泌学》。3.宣泰医药恩杂鲁胺片获FDA暂时批准6月26日，上海宣泰医药科技股份有限公司发布公告称，公司恩杂鲁胺片向FDA申报的仿制药申请获得暂时批准。恩杂鲁胺片是一种雄激素受体抑制剂，本次获批的适应症为：1）去势抵抗性前列腺癌；2）转移性去势敏感性前列腺癌。此外，该产品已于2024 年8 月在中国提交注册申请。(来源：健识局作者：小米）药闻康策新媒体矩阵微信公众号点击下方一键关注【免责声明】1.“药闻康策”部分文章信息来源于网络转载是出于传递更多信息之目的，并不意味着赞同其观点或证实其内容的真实性。如对内容有疑议，请及时与我司联系。2.“药闻康策”致力于提供合理、准确、完整的资讯信息，但不保证信息的合理性、准确性和完整性，且不对因信息的不合理、不准确或遗漏导致的任何损失或损害承担责任。3.“药闻康策”所有信息仅供参考，不做任何商业交易或医疗服务的根据，如自行使用“药闻康策”内容发生偏差，我司不承担任何责任，包括但不限于法律责任，赔偿责任。欢迎转发分享、点赞、点在看

高管变更疫苗引进/卖出

2025-06-27

·FiercePharma

Fierce Pharma Asia—Vor-RemeGen, Otsuka-Harbour autoimmune deals; Datroway's lung cancer nod

Vor Bio and RemeGen's market-dividing licensing deal, Otsuka and Harbour BioMed's BCMA T-cell engager pact, and Datroway's second FDA nod made our news this week. A potential $4 billion licensing deal with Vor Bio triggered a slide in RemeGen's stock price. Otsuka obtained a BCMAXCD3 bispecific from Harbour BioMed to develop against autoimmune diseases. AstraZeneca and Daiichi Sankyo's Datroway secured a lung cancer approval from the FDA. And more.1. Vor Bio's surprise $4B revival deal for RemeGen's autoimmune drug triggers divergent stock reactionsOn the brink of shutting down, Vor Bio has been revived by a licensing deal with China’s RemeGen. For $45 million upfront and up to $4.1 billion in milestones, the Massachusetts biotech is gaining ex-China rights to RemeGen’s BLyS/APRIL dual-target fusion protein telitacicept, which is approved in China to treat several autoimmune diseases. However, RemeGen’s stock price dropped sharply after the news.2. Otsuka pens $670M pact to point Harbour's preclinical T-cell engager toward autoimmune diseaseIn another autoimmune-focused deal involving a Chinese biotech, Otsuka agreed to pay Harbour BioMed $47 million upfront for ex-China rights to a preclinical BCMAxCD3 bispecific candidate. While Harbour got the Chinese green light to test the asset in cancer patients, Otsuka plans to test the drug, HBM7020, against autoimmune conditions.3. AZ, Daiichi's Datroway scores its 2nd FDA approval—this time in lung cancer subsetAstraZeneca and Daiichi Sankyo’s TROP2-targeted antibody-drug conjugate Datroway has picked up its second FDA nod after a refile. Datroway secured the EGFR-mutated non-small cell lung cancer indication after the companies had withdrawn an earlier application in nonsquamous NSCLC following a phase 3 overall survival miss.4. Corxel, Sciwind post GLP-1 data as China's obesity push gathers paceGLP-1 assets from China are showing their power at the American Diabetes Association Scientific Sessions. Sciwind’s phase 3 data linked its injectable GLP-1 receptor agonist ecnoglutide to a mean weight loss of 15.4% after 48 weeks. Phase 2 data on Corxel and Vincentage’s small-molecule GLP-1 candidate showed a 9.7% weight reduction in 16 weeks when given at a fast titration to the highest dose.5. BrightGene tops Novo drug in diabetes ahead of Zepbound showdownAlso at ADA, China’s BrightGene reported that its GLP-1/GIP receptor agonist BGM0504 topped Novo Nordisk’s Ozempic in Chinese patients with Type 2 diabetes in a midstage trial. The drug saw dose-dependent reductions in HbA1c of up to 2.48% after 12 weeks, versus 1.43% for Ozempic and 0.28% for placebo. The biotech also shared phase 2 obesity data comparing BGM0504 against placebo, and the company is pitting the drug against Eli Lilly’s Zepbound in another phase 2 study.6. FDA moves to block Olympus endoscope imports over manufacturing issuesThe FDA warned healthcare providers that it’s shutting down imports of 58 models of aparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories, made by Olympus. The agency cited concerns around quality requirements at a production site in Japan.Other News of Note:7. GSK, Bharat Biotech to slash the price of first malaria vaccine to less than $5 per dose by 20288. Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug9. Arbutus regains China rights to potential functional hep B cure as part of strategic rethink10. Korea’s Abion Bio inks $1.3B deal over CLDN3, other cancer targets (Korea Biomedical Review)

临床结果临床3期上市批准临床2期引进/卖出

2025-06-24

·同写意

下一代GLP-1疗法最新进展盘点：来自礼来、诺和诺德、安进……

同写意年度巨献！！大会特设“GLP-1全产业链创新发展”分会，7月25-26日，邀您相聚金鸡湖畔，与5000人一起为中国医药创新“同写意”！第85届美国糖尿病协会（ADA）科学年会已经在美国芝加哥落下帷幕。ADA年会是全球规模最大的糖尿病和代谢疾病学术会议之一，本届年会上，多家生物医药公司汇报了基于胰高血糖素样肽-1（GLP-1）信号通路开发的创新疗法的最新临床试验结果。GLP-1药物是治疗糖尿病和肥胖症的研发热点之一，目前全球已有超过80款相关药物或药物组合进入临床开发阶段，其中多肽疗法仍是主流。在GLP-1药物开发热潮到来之前，药明康德旗下的WuXi TIDES早已围绕多肽药物建立了一体化CRDMO平台，提供所有类型的多肽，包括线性、环状和高度修饰的多肽，以及非天然氨基酸、连接子、毒素和多肽偶联药物的合成服务，支持从药物发现、CMC开发到商业化生产的各个阶段，助力合作伙伴更高效地为患者提供新一代GLP-1疗法。本文将与读者分享在ADA年会上公布的GLP-1药物的最新研发进展。TONACEA01减掉的超过90%是脂肪！组合疗法2期临床结果公布研究人员公布了礼来公司（Eli Lilly and Company）开发的在研疗法bimagrumab与诺和诺德公司（Novo Nordisk）的GLP-1药物Wegovy（司美格鲁肽）联用，治疗肥胖症的2b期临床试验BELIEVE的最新结果。Bimagrumab是一款潜在“first-in-class"的单克隆抗体，靶向激活素2型受体（ActRII）。ActRII是在脂肪和肌肉细胞中都表达的激活素受体。ActRII受体激活可引发肌肉萎缩并促进脂肪组织中脂肪的堆积。通过阻断该通路，有望在减少脂肪的同时，改善患者的肌肉组成。试验数据显示，接受bimagrumab/Wegovy组合疗法治疗的受试者在72周后体重平均降低22.1%。值得注意的是，丢失的体重中92.8%源于脂肪组织减少。与单药治疗相比，该组合在减少腹部脂肪和炎症相关生物标志物方面也显示出更显著的疗效。TONACEA02体重减轻约20%，安进MariTide完整2期结果发布安进公司（Amgen）今日公布了其在研药物MariTide（maridebart cafraglutide，前称AMG 133）2期临床试验第一部分的完整结果。MariTide是一款潜在“first-in-class”的在研抗体多肽偶联药物，在靶向胃抑制肽受体（GIPR）的单克隆抗体的特定位点上偶联了两个GLP-1类似物，在激活GLP-1受体的同时抑制GIPR。它可通过皮下注射每月或更低频率给药。相关研究结果同时发表于《新英格兰医学杂志》。在2期研究中，MariTide在无2型糖尿病的肥胖人群中实现了最高约20%的平均体重减轻，而安慰剂组为2.6%；在患有糖尿病的肥胖人群中，MariTide组的体重平均减轻最高可达约17%，而安慰剂组仅为1.4%。在第52周时，体重减轻仍未出现平台期，显示出进一步减重的潜力。除了显著的减重效果外，MariTide还在患有糖尿病的肥胖人群中实现了最高达2.2个百分点的糖化血红蛋白（HbA1c）持续且显著下降。体重下降还伴随着一系列心血管代谢指标的改善，包括腰围、血压、高敏C反应蛋白（hs-CRP）及部分血脂参数的改善。▲MariTide的2期临床试验主要疗效结果（图片来源：参考资料[7]）TONACEA03礼来口服GLP-1激动剂3期结果，登《新英格兰医学杂志》礼来公司公布了ACHIEVE-1研究的详细结果。这项3期临床试验评估了orforglipron在仅通过饮食和锻炼控制血糖仍不理想的2型糖尿病成人患者中的安全性与有效性。新闻稿指出，orforglipron是首款完成3期临床试验的口服小分子（非肽类）GLP-1受体激动剂，在服用过程中不受进食与饮水的限制。在第40周时，orforglipron的3种剂量（3 mg、12 mg、36 mg）均达到主要终点，即在降低HbA1c方面优于安慰剂。此外，12 mg和36 mg剂量在体重减轻方面也表现出具有临床意义和统计学显著性的优势。研究显示，orforglipron的安全性特征与已有GLP-1药物相似，最常见的不良事件为胃肠道相关反应。相关结果已在ADA科学年会上公布，并同步发表于《新英格兰医学杂志》。在研究中，orforglipron在第40周达到主要终点，与安慰剂相比，其HbA1c下降幅度为1.3至1.6个百分点。在关键性次要终点方面，最多达76.2%的orforglipron受试者实现了ADA设定的治疗目标HbA1c＜7个百分点；66.0%的受试者达到HbA1c≤6.5个百分点；25.8%的受试者达到HbA1c＜5.7个百分点，即正常HbA1c范围。在另一项关键性次要终点中，接受最高剂量orforglipron治疗的受试者平均减重16.0磅（7.9%）。更长期的研究（如ATTAIN研究）将进一步全面评估orforglipron在肥胖治疗中的安全性与疗效。Orforglipron是一种每日一次的在研口服小分子GLP-1受体激动剂。它由Chugai Pharmaceutical发现，并于2018年授权给礼来公司。目前，礼来正开展orforglipron治疗2型糖尿病，以及治疗肥胖或超重成人患者的3期研究。TONACEA04诺和诺德amycretin早期临床结果登《柳叶刀》，直接进入3期临床试验诺和诺德公司宣布，在研创新肥胖治疗药物amycretin的两项早期临床试验结果在《柳叶刀》杂志上发布。Amycretin是诺和诺德正在研发的一种单分子长效GLP-1和胰淀素受体激动剂，拟用于治疗成人超重或肥胖人群，以及2型糖尿病患者。皮下注射amycretin的1b/2a期试验结果显示，治疗伴发不良事件（TEAEs）多数为轻度或中度，其发生频率呈剂量依赖性升高。最常见的不良事件为胃肠道相关症状。与安慰剂相比，接受amycretin治疗的受试者在研究的所有剂量范围内均观察到更显著的体重下降。接受最高剂量（60 mg）治疗的受试者在36周治疗后体重平均减轻幅度可达24.3%，而安慰剂组仅为1.1%。这一研究结果支持继续探索amycretin在减重方面的潜在疗效。已发表的口服amycretin的1期研究结果显示，最常见的不良事件为胃肠道症状以及食欲下降，且在较高剂量组中更为常见。接受治疗的受试者在所有剂量组中均显示出明显优于安慰剂组的体重减轻效果。探索性分析显示，每日口服100 mg amycretin的受试者在12周后平均体重减轻幅度为13.1%，而安慰剂组仅为1.2%。基于上述及其他已完成的临床研究结果，并结合监管机构的反馈意见，诺和诺德将推进口服与皮下注射两种剂型的amycretin进入3期临床开发，用于体重管理。TONACEA05体重减轻超13%，先为达生物偏向性GLP-1类似物3期临床结果发布先为达生物在ADA年会上发布了其在研cAMP偏向性GLP-1类似物埃诺格鲁肽（ecnoglutide）注射液的3期临床试验结果。该结果同时在The Lancet Diabetes and Endocrinology上发表。Ecnoglutide的cAMP偏向性可能通过降低GLP-1受体的内化和增强胰岛素的分泌来增强GLP-1受体激动剂的临床效果。在2023年4月5日至2024年6月20日期间，这项3期临床试验中，664人被随机分配接受不同剂量的ecnoglutide或安慰剂治疗。在第40周，体重的最小二乘均值百分比变化分别为：ecnoglutide 1.2毫克组为-9.1%，1.8毫克组为-10.9%，2.4毫克组为-13.2%，而安慰剂组为0.1%。与安慰剂相比，各剂量组的预估治疗差值分别为-9.2%、-11.1%和-13.3%，所有比较的p值均<0.0001。在第40周，体重减少≥5%的受试者比例为：ecnoglutide 1.2毫克组为77%，1.8毫克组为84%，2.4毫克组为87%，而安慰剂组仅为16%。GLP-1药物已在治疗2型糖尿病和肥胖方面展现出卓越疗效。ADA年会上公布的最新进展显示，新一代GLP-1药物正通过多种策略提升疗效、安全性和便捷性。药明康德很高兴能够为多款GLP-1药物赋能。今年摩根大通医疗健康大会的报告指出，2024年，公司赋能的临床阶段GLP-1管线从13个增加到20个。其中包括9个临床期多肽药物和11个临床期小分子药物，积极助力新一代GLP-1药物早日触达患者。展望未来，药明康德将继续秉持“让天下没有难做的药，难治的病”的愿景，依托全球研发基地与生产网络，凭借独特的一体化、端到端CRDMO模式，持续推动新一代GLP-1药物的开发进程，造福全球患者。参考资料：（上下滑动查看更多）[1] Novo Nordisk advances early-stage obesity medication, amycretin, to phase 3 clinical development based on early-phase clinical trial results in people with obesity or excess weight, published in The Lancet. Retrieved June 20, 2025, from https://www.prnewswire.com/news-releases/novo-nordisk-advances-early-stage-obesity-medication-amycretin-to-phase-3-clinical-development-based-on-early-phase-clinical-trial-results-in-people-with-obesity-or-excess-weight-published-in-the-lancet-302487500.html[2] Lilly's oral GLP-1, orforglipron, showed compelling efficacy and a safety profile consistent with injectable GLP-1 medicines, in complete Phase 3 results published in The New England Journal of Medicine. Retrieved June 21, 2025, from https://www.prnewswire.com/news-releases/lillys-oral-glp-1-orforglipron-showed-compelling-efficacy-and-a-safety-profile-consistent-with-injectable-glp-1-medicines-in-complete-phase-3-results-published-in-the-new-england-journal-of-medicine-302487392.html[3] Verdiva Bio to Present New Data Highlighting Once-Weekly Potential of Its Investigational Oral Obesity Candidates at the ADA 85th Scientific Sessions. Retrieved June 21, 2025, from https://www.businesswire.com/news/home/20250620108098/en/Verdiva-Bio-to-Present-New-Data-Highlighting-Once-Weekly-Potential-of-Its-Investigational-Oral-Obesity-Candidates-at-the-ADA-85th-Scientific-Sessions[4] Lilly’s bimagrumab boosts weight and fat loss when added to Novo's Wegovy. Retrieved June 23, 2025, from https://endpoints.news/ada25-lillys-bimagrumab-boosts-weight-and-fat-loss-when-added-to-novos-wegovy/[5] Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine. Retrieved June 23, 2025, from https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916353[6] RESULTS FROM AMGEN'S PHASE 2 OBESITY STUDY OF MONTHLY MARITIDE PRESENTED AT THE AMERICAN DIABETES ASSOCIATION 85TH SCIENTIFIC SESSIONS. Retrieved June 23, 2025, from https://www.prnewswire.com/news-releases/results-from-amgens-phase-2-obesity-study-of-monthly-maritide-presented-at-the-american-diabetes-association-85th-scientific-sessions-302487811.html[7] Jastreboff et al., (2025). Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial. NEJM, DOI: 10.1056/NEJMoa2504214

100 项与伊诺格鲁肽相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肥胖	申请上市	中国	杭州先为达生物科技股份有限公司	2024-12-17
肥胖	申请上市	中国	美药星（南京）制药有限公司	2024-12-17
2型糖尿病	申请上市	中国	杭州先为达生物科技股份有限公司	2024-11-23
2型糖尿病	申请上市	中国	美药星（南京）制药有限公司	2024-11-23
糖尿病	临床3期	-	HK inno.N Corp.	-
肾功能不全	临床1期	中国	杭州先为达生物科技股份有限公司	2023-08-21
非酒精性脂肪性肝炎	临床1期	中国	杭州先为达生物科技股份有限公司	2021-06-16
阿尔茨海默症	临床前	中国	杭州先为达生物科技股份有限公司	2023-05-19

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS 人工标引	临床3期	肥胖	-	ecnoglutide	壓蓋醖選願艱艱蓋淵簾(鹹積選築膚繭簾艱簾糧) = 蓋鹽夢襯觸憲獵製艱壓顧窪鬱膚壓網鹹鹽網鑰 (夢構鹽鬱構積淵顧鏇蓋 )	积极	2025-06-27
NCT05813795 (Lancet \| NEWS) 人工标引	临床3期	超重 \| 肥胖	664	ecnoglutide 1.2 mg	繭顧繭選鏇淵範餘鹽鹹(廠願顧鑰蓋淵願鹽願夢) = 壓顧鏇選遞築遞繭窪壓範鏇顧膚鹽顧鬱鹽鏇選 (鹹繭築淵願齋網簾範顧, 0.8) 更多	积极	2025-06-21
				ecnoglutide 1.8 mg	繭顧繭選鏇淵範餘鹽鹹(廠願顧鑰蓋淵願鹽願夢) = 壓糧選選襯齋積範選網範鏇顧膚鹽顧鬱鹽鏇選 (鹹繭築淵願齋網簾範顧, 0.9) 更多
CTR20211014 (Literature) 人工标引	临床2期	2型糖尿病	145	Ecnoglutide 0.4 mg	醖憲構願繭廠築窪蓋構(醖襯襯鑰顧製壓選壓獵) = 壓鹹築齋蓋觸膚餘餘襯遞鹽簾襯鹹遞壓簾衊簾 (簾衊獵糧憲鏇淵鏇鏇鹽 ) 更多	积极	2024-09-27
				Ecnoglutide 0.8 mg	醖憲構願繭廠築窪蓋構(醖襯襯鑰顧製壓選壓獵) = 糧觸衊憲鑰鹹網醖繭鑰遞鹽簾襯鹹遞壓簾衊簾 (簾衊獵糧憲鏇淵鏇鏇鹽 )
NCT05680155 (ADA2024) 人工标引	临床3期	2型糖尿病	211	Ecnoglutide 0.6 mg	簾簾願鏇範鬱衊餘選夢(遞夢廠膚廠餘構廠築憲) = 淵遞襯積鏇憲衊壓範齋窪廠築簾鹽糧網窪蓋構 (夢襯顧衊積膚鬱廠願鑰 ) 更多	积极	2024-06-21
				Ecnoglutide 1.2 mg	簾簾願鏇範鬱衊餘選夢(遞夢廠膚廠餘構廠築憲) = 淵糧構窪醖齋範鏇鏇積窪廠築簾鹽糧網窪蓋構 (夢襯顧衊積膚鬱廠願鑰 ) 更多
NCT05184322 (ADA2024) 人工标引	临床1期	肥胖	56	Oral Ecnoglutide 7mg (healthy)	製膚簾顧憲襯鬱鹽膚鹹(廠築淵淵廠遞選獵淵願) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. 壓繭構窪構鹹鹽獵觸餘 (範顧範遞製餘積膚鏇簾 ) 更多	积极	2024-06-21
				Oral Ecnoglutide 15mg (healthy)
ADA2024	N/A	-	-	Ecnoglutide	艱網製衊範廠齋壓構鹽(鏇壓壓築獵蓋構鏇觸齋) = 鬱艱積艱鑰醖憲蓋蓋選觸鑰壓襯遞餘鏇顧簾鹽 (範構鏇範觸夢艱壓繭網 )	-	2024-06-14
				Semaglutide	艱網製衊範廠齋壓構鹽(鏇壓壓築獵蓋構鏇觸齋) = 膚廠糧夢鏇選齋蓋夢構觸鑰壓襯遞餘鏇顧簾鹽 (範構鏇範觸夢艱壓繭網, -1.86)
NEWS 人工标引	临床1期	肥胖	56	ecnoglutide	觸鹹襯築觸選選鹹窪膚(網築鹹構觸網廠積膚鏇) = 最常见的不良事件包括恶心、头痛、腹泻、呕吐和食欲减退，大多数不良事件的严重程度为轻中度，主要发生在剂量递增期糧餘鏇顧鑰構鑰艱獵顧 (淵淵願繭構夢壓鏇糧窪 )	积极	2024-01-24
				placebo
NCT05680155 (NEWS) 人工标引	临床3期	2型糖尿病	211	Ecnoglutide 0.6 mg	夢鏇憲繭衊衊壓艱齋願(築顧鏇網網願顧鹹簾壓) = 艱齋齋窪遞鬱築獵鬱夢獵襯積壓構鹽夢淵鹹淵 (觸齋鬱窪蓋製廠鏇夢窪 ) 更多	积极	2024-01-03
				Ecnoglutide 1.2 mg	夢鏇憲繭衊衊壓艱齋願(築顧鏇網網願顧鹹簾壓) = 醖襯膚簾壓鏇糧獵鑰醖獵襯積壓構鹽夢淵鹹淵 (觸齋鬱窪蓋製廠鏇夢窪 ) 更多
NCT05111912 (ADA 12023 \| ADA 22023) 人工标引	临床2期	肥胖	206	XW003 1.2 mg	鏇糧簾窪積醖網選製鬱(艱衊積蓋窪獵簾鏇獵製) = 餘艱構鑰齋積繭糧餘構網糧糧鏇積願淵築構艱 (餘襯鑰遞憲蓋憲顧範膚 )	积极	2023-06-20
				XW003 1.8 mg	鏇糧簾窪積醖網選製鬱(艱衊積蓋窪獵簾鏇獵製) = 觸糧齋鏇襯簾構選衊簾網糧糧鏇積願淵築構艱 (餘襯鑰遞憲蓋憲顧範膚 )
CTR20211014 (ADA 12023 \| ADA 22023) 人工标引	临床2期	2型糖尿病	145	XW003 0.4 mg	繭齋蓋糧製製選獵觸壓(範製鹹鏇鹽簾顧醖糧積) = 觸艱製蓋網網顧鏇鬱淵鏇艱夢選鹽網糧窪襯廠 (廠選夢製壓齋範鏇選鹽 ) 更多	积极	2023-06-20
				XW003 0.8 mg	繭齋蓋糧製製選獵觸壓(範製鹹鏇鹽簾顧醖糧積) = 鏇壓糧鑰願顧願鬱網壓鏇艱夢選鹽網糧窪襯廠 (廠選夢製壓齋範鏇選鹽 ) 更多